The Global Medical Affairs Therapeutics Area Leader, Ophthalmology is a critical member of the Medical Affairs leadership team and is responsible for defining the global Medical Affairs vision, strategies & tactics that support the safe and appropriate use of LUXTURNA as well as Spark’s late stage Ophthalmology asset development.
They will lead efforts in key opinion leader (KOL) identification and development, analysis and interpretation of clinical results for medical education, presentations and publications, and health economics support.
They will provide strategic guidance for Phase IV and investigator-initiated research activities, assist in evaluation of new business development opportunities, and support clinical trial investigators and trial enrollment as needed.
They will work closely with Spark’s Patient Advocacy group to interface with Ophthalmology advocacy groups as appropriate.
They will serve as the Spark subject matter expert in Ophthalmology for all stakeholders of the Spark organization.
They will work with the MSL Leadership team for facilitate strategy development & implantation. Incumbent will manage & develop the careers of Medical Affairs Ophthalmology team members.
- Define and lead medical strategy development & implementation in gene-based therapeutics for ocular disorders, to support development and commercialization of LUXTURNA and other ocular-targets assets in development
- Plan and execute medical advisory boards globally as needed to obtain insight for medical affairs activities, as well as gain KOL feedback on commercial, clinical and other activities
- Define KOL targets and strategy for medical advocacy development; lead KOL speaker training activities
- Lead data analysis for Medical Affairs and provide strategic guidance for and review of scientific publications and medical education initiatives, HEOR evidence generation, payer presentations
- Deliver presentations of Spark Ophthalmology data at medical congresses, represent Spark at relevant scientific, clinical and advocacy meetings
- Define research areas of interest & execute t the Competitive Grant Program project
- Provide medical oversight of the promotional review process, in conjunction with the Medical Information function
- Provide subject matter expertise into all Spark stakeholders, e.g. Regulatory and Clinical Development activities as needed/appropriate
- Provide subject matter expertise and review of materials for Corporate Communications and other corporate functions as needed/appropriate
- Provide strategic and direct leadership to US, EU, and Rest-of-World (Novartis) Ophthalmology medical team members.
- Manage performance of every team member, provide continuous and on-going performance feedback, hold every team member accountable to achieve results while demonstrating the Spark Values.
- Ensure individual objectives align to corporate and functional objectives.
- Develop team members’ careers by continually growing employees through challenging experiences, identify areas for development, actively coach, provide development and learning opportunities.
- Foster Sparks Culture and lead by example. Create an environment where team members thrive in Spark’s culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to team members that how they achieve performance objectives is just as important as what they accomplish.
- Provide critical analysis of new business opportunities and potential new product candidates from a clinical perspective; participate in evaluations and due diligence activities
- Provide medical/clinical insight into competitive developments
- MD/DO/MBBS or equivalent required; significant clinical and/or industry Ophthalmology experience
- Vitreoretinal Surgeon VERY HIGHLY preferred
- Ophthalmologic Surgeon credentials/experience required
- Well established credibility among the Ophthalmology specialized community of KOLs
- 7-10 years of global pharmaceutical/biotech industry experience preferred
- Prior management experience in an international environment preferred
- Demonstrated ability to manage and motivate internal and external team members
- Demonstrated experience in multiple phases of development preferred; post-marketing trial experience required
- Must have demonstrated successful track record of KOL interactions and relationship development in the Ophthalmology space
- Experience with creating and delivering clinical value presentations to payer audiences preferred
- Experience with designing and running post-marketing trials; experience with registries preferred
- Superior Understanding of medical affairs functions and deliverables
- Superior Ability to analyze data and synthesize a compelling scientific narrative tailored to relevant audiences
- Strong written communication and presentation skills
- Proficient in Microsoft Office applications
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.